Decaflu for fever and pain

Patient information leaflet

Decaflu Fever and Pain Children 100 mg/5 ml oral suspension, orange flavour sugar-free, strawberry flavour sugar-free

Ibuprofen
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your condition worsens:
• after 24 hours if the infant is aged between 3 and 5 months
• after 3 days if the infant or child is over 6 months of age

Contents of this leaflet:

1. What Decaflu Fever and Pain is and what it is used for
2. What you need to know before using Decaflu Fever and Pain
3. How to use Decaflu Fever and Pain
4. Possible side effects
5. How to store Decaflu Fever and Pain
6. Package contents and other information

1. What Decaflu Fever and Pain is and what it is used for

Decaflu Fever and Pain contains ibuprofen, which belongs to a group of medicines called "non-steroidal anti-inflammatory drugs (NSAIDs)", whose action helps reduce pain, fever, and inflammation.
Decaflu Fever and Pain is indicated in children from 3 months to 12 years of age, adolescents, and adults for the symptomatic treatment of fever, and mild to moderate pain.

2. What you need to know before using Decaflu Fever and Pain

Do not use Decaflu Fever and Pain if the child:

• is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• has had or currently has allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips, or throat (angioedema), or hives, particularly if associated with nasal polyps and asthma, after taking other painkillers, antipyretics, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• suffers from severe kidney or liver disease (severe renal or hepatic insufficiency);
• suffers from severe heart disease (severe heart failure);
• has had or currently has gastrointestinal bleeding and/or perforation following previous treatment with NSAIDs;
• has had or currently suffers from gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of proven ulceration or bleeding);
• is currently taking other non-steroidal anti-inflammatory drugs (NSAIDs, including COX-2 inhibitors) (see section “Other medicines and Decaflu Fever and Pain”);
• has any condition that increases the risk of bleeding;
• has unexplained blood disorders;
• is severely dehydrated, for example due to severe episodes of vomiting, diarrhea, or very low fluid intake;
• is under 3 months of age or weighs less than 5.6 kg;
• is in the last trimester of pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using Decaflu Fever and Pain if the child:

• has had or currently suffers from allergy to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs), or suffers from breathing difficulties (asthma), nasal polyps, or swelling of the face, lips, or throat (angioedema);
• is taking other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors) (see section “Other medicines and Decaflu Fever and Pain”);
• has had stomach or intestinal problems (history of ulcers), especially if complicated by bleeding or perforation, as there may be an increased risk of gastrointestinal bleeding and perforation. In such cases, your doctor may advise starting treatment with the lowest available dose and possibly using concomitant stomach-protective medicines (misoprostol or proton pump inhibitors). This should also be considered if low-dose aspirin or other medicines increasing the risk of stomach and intestinal disorders are being taken (see section “Other medicines and Decaflu Fever and Pain”). During treatment with any NSAID, gastrointestinal bleeding, ulceration, or perforation may occur at any time, with or without warning symptoms or previous history of serious gastrointestinal events, and may be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Decaflu Fever and Pain and contact your doctor immediately;
• has had or currently suffers from inflammatory bowel disease (ulcerative colitis, Crohn’s disease), as these conditions may worsen (see section “Possible side effects”);
• is taking medicines that may increase the risk of ulcer or bleeding, such as medicines used to treat inflammation and certain immune system disorders (oral corticosteroids), anticoagulants such as warfarin, medicines with antiplatelet effects like aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and Decaflu Fever and Pain”);
• has heart disease (uncontrolled hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease) or has had reduced blood flow to the brain (stroke), or if you think that you or the child may be at risk for these conditions (e.g., if you have high blood pressure, high blood sugar levels (diabetes), high blood lipid levels, or smoke). Medicines like Decaflu Fever and Pain may be associated with a slight increase in the risk of heart attack or stroke: this risk is more likely at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• has high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (edema) have been reported in association with NSAID therapy;
• has an infection (see section “Infections” below);
• has chickenpox, as use of Decaflu Fever and Pain should be avoided in this case.

Use of Decaflu Fever and Pain requires adequate precautions, especially if:

• the child has had or currently suffers from asthma, as breathing difficulties may worsen;
• the child has coagulation disorders or hypertension;
• the child has kidney, heart, or liver disease and is taking diuretics (medicines that increase urine production), or has undergone major surgery with consequent fluid loss, as your doctor may recommend periodic blood and urine tests;
• the child has recently undergone major surgery;
• the child has certain inherited disorders affecting blood formation (e.g., acute intermittent porphyria); or is dehydrated (e.g., due to fever, vomiting, or diarrhea), in which case rehydrate the child before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatment with Decaflu Fever and Pain, pay particular attention and inform your doctor immediately if any of the following occur:

• signs or symptoms of stomach or intestinal ulceration or bleeding (e.g., black, foul-smelling stools, vomiting blood);
• signs or symptoms of liver damage (e.g., hepatitis, jaundice);
• signs or symptoms of kidney damage (e.g., increased urine output, blood in urine);
• visual disturbances (blurred or reduced vision, areas of complete or partial blindness, color perception changes);
• symptoms such as frequent or daily headaches despite regular use of headache medicines, which may be caused by excessive use of these medicines;
• symptoms such as headache, disorientation, nausea, vomiting, stiff neck, and fever, as these may indicate aseptic meningitis (more common if the child has systemic lupus erythematosus or other collagen vascular diseases).

Skin reactions
Serious skin reactions have been reported with Decaflu Fever and Pain treatment.
Stop treatment with Decaflu Fever and Pain and consult your doctor immediately if a rash, mucosal lesions, blisters, or other signs of allergy appear, as these may be early signs of a severe skin reaction. See section 4.
Infections
Decaflu Fever and Pain may mask symptoms of infections such as fever and pain. Therefore, Decaflu Fever and Pain may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Other medicines and Decaflu Fever and Pain
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Decaflu Fever and Pain may affect or be affected by other medicines. In particular, inform your doctor or pharmacist if you are taking:

• other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors or acetylsalicylic acid). Such combinations should be avoided as they increase the risk of adverse effects;
• medicines used to treat inflammation and certain immune system disorders (corticosteroids);
• medicines used to treat bacterial infections (quinolone antibiotics);
• medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat depression such as selective serotonin reuptake inhibitors;
• a medicine used to treat seizures (phenytoin);
• antidiabetic medicines for high blood sugar (sulfonylureas);
• a medicine used to treat viral infections (ritonavir);
• medicines that modulate the immune response (tacrolimus and cyclosporine);
• a medicine used in cancer and rheumatism treatment (methotrexate);
• a medicine used for mental illness (lithium);
• a medicine used for medical termination of pregnancy (mifepristone): do not take NSAIDs within 8–12 days after taking mifepristone;
• a medicine used to treat gout (probenecid and sulfinpyrazone);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan) and diuretics;
• potassium-sparing diuretics;
• CYP2C9 inhibitors (e.g., voriconazole, fluconazole), since concomitant administration of ibuprofen and CYP2C9 inhibitors may slow down ibuprofen elimination (a CYP2C9 substrate), leading to increased exposure to ibuprofen;
• medicines used to treat heart conditions (cardiac glycosides such as digoxin);
• zidovudine (a medicine for the treatment of HIV/AIDS).

Decaflu Fever and Pain with food and drinks
The medicine can be taken either with or without food.
Possible stomach-related side effects, if present, may be reduced by taking the medicine with food.
Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is unlikely that individuals aged 12 years or younger will become pregnant or breastfeed.
Pregnancy
Do not take this medicine during the last 3 months of pregnancy, as it may harm the unborn baby or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both you and the baby and may cause delayed or prolonged labor. This medicine should not be used during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Do not use Decaflu Fever and Pain during the third trimester of pregnancy.
Breastfeeding
This medicine passes into breast milk in small amounts. It may be used during breastfeeding if taken at the recommended doses and for short periods.
Fertility
Decaflu Fever and Pain with food and drinks
The medicine can be taken either with or without food.
Possible stomach-related side effects, if present, may be reduced by taking the medicine with food.
Decaflu Fever and Pain contains:

• Maltitol: if your doctor has diagnosed the child with intolerance to certain sugars (e.g., fructose), contact your doctor before using this medicine.
• Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”:
  • 4.51 mg of sodium per 2.5 ml dose of suspension;
  • 9.02 mg of sodium per 5 ml dose of suspension;
  • 13.53 mg of sodium per 7.5 ml dose of suspension;
  • 18.04 mg of sodium per 10 ml dose of suspension;

For a 15 ml dose of suspension, this medicine contains 27.06 mg of sodium, which corresponds to 1.35% of the maximum daily intake recommended by the WHO (2 g of sodium for an adult).

• Sodium benzoate:
  • 0.025 mg of sodium benzoate per 2.5 ml dose of suspension;
  • 0.05 mg of sodium benzoate per 5 ml dose of suspension;
  • 0.075 mg of sodium benzoate per 7.5 ml dose of suspension;
  • 0.1 mg of sodium benzoate per 10 ml dose of suspension;
  • 0.15 mg of sodium benzoate per 15 ml dose of suspension.

Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks).

3. How to take Decaflu Fever and Pain

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended daily dose is based on the child's weight and age.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If your child has an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
To reduce the risk of possible side effects, the lowest effective dose should be used for the shortest time needed to control symptoms (see section 4).
Use in children aged between 3 and 6 months

• In children aged between 3 and 6 months, limit administration to those weighing more than 5.6 kg.
• The daily oral dose for infants and children aged between 3 months and 12 years can be administered using the dosing syringe provided with the product.

The daily dose of 20–30 mg/kg body weight, divided into three doses per day at intervals of 6–8 hours, may be administered according to the following schedule (calculate the dose to be administered based on the weight shown in the table and the child's age).

The graduated scale on the syringe clearly shows markings for different dosages; in particular,
the 2.5 ml mark corresponds to 50 mg of ibuprofen and the 5 ml mark corresponds to 100 mg of
ibuprofen.
If you suffer from stomach problems, take Decaflu Febbre e Dolore preferably during meals.
In the case of post-vaccination fever, follow the dosage indicated above, administering a single dose (2.5 ml), followed, if necessary, by another dose after 6 hours. Do not administer more than two doses within 24 hours. Consult your doctor if fever does not decrease.
Decaflu Febbre e Dolore should be administered for short-term treatment only.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after:
24 hours in infants aged between 3 and 5 months;
3 days in infants and children over 6 months of age and in adolescents.
Instructions for using the dosing syringe. Unscrew the cap by pushing it downward and turning it to the left.

• Insert the tip of the syringe fully into the hole in the inner cap.
• Shake well.
• Invert the bottle, then, holding the syringe firmly, gently pull the plunger downward to draw the suspension into the syringe up to the mark corresponding to the desired dose. Return the bottle to an upright position and remove the syringe by gently rotating it.
• Insert the tip of the syringe into the mouth and gently press the plunger to dispense the suspension.
• After use, screw the cap back on to close the bottle and wash the syringe with warm water. Leave it to dry, keeping it out of sight and reach of children.

If you use more Decaflu Febbre e Dolore than you should
If you have taken more Decaflu Febbre e Dolore than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on potential risks and actions to take.
Symptoms may include: nausea, stomach ache, vomiting (possibly with traces of blood), deep drowsiness with reduced response to normal stimuli (lethargy), headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, it may cause: uncontrolled eye movements (nystagmus), increased levels of acid in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney problems, bleeding of the stomach and intestines, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, disorientation, agitation, fainting, low blood pressure (hypotension), and decreased or increased heart rate (bradycardia or tachycardia) may occur.
If significantly high doses of ibuprofen are taken, serious kidney and liver damage may occur.
Decaflu Febbre e Dolore
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Decaflu Fever and Pain can cause side effects, although not everybody will experience them.
If you experience any of the following side effects, STOP using Decaflu Fever and Pain and contact your doctor:

• severe skin and mucous membrane reactions characterized by rashes, redness, itching, and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis);
• allergic reactions, even severe ones, which may include: urticaria, itching, purpura, swelling of the face, mouth, and throat (angioedema), breathing difficulties (bronchospasm or dyspnea), irregular heartbeats (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, neck stiffness, and fever (more frequent if you have systemic lupus erythematosus or other collagen diseases).

Other side effects include:
Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, drowsiness, and seizures;
• stomach pain, nausea, and indigestion (dyspepsia);
• skin rashes.

Rare (may affect up to 1 in 1,000 people):

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, mood instability, hearing and vision disturbances;
• cerebral hemorrhage;
• dry eyes;
• awareness of heartbeat (palpitations);
• diarrhea, flatulence, dry mouth, constipation, and vomiting;
• hair loss (alopecia);
• skin becomes sensitive to light;
• serious kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine, and increased urine production;
• decreased hematocrit levels.

Very rare (may affect up to 1 in 10,000 people):

• reduction in blood cell counts (anemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and bleeding;
• signs or symptoms of stomach or intestinal ulcers or bleeding, black and foul-smelling stools, vomiting blood;
• bleeding lesions in the mouth, stomach burning (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, liver dysfunction, hepatitis, jaundice);
• serious kidney diseases (acute renal failure, papillary necrosis), particularly after long-term treatment, associated with increased blood urea concentration and swelling (edema);
• decreased hemoglobin levels in the blood;
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of inflammation related to infections (e.g., necrotizing fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of infection appear or worsen, seek immediate medical advice to determine whether anti-infective/antibiotic therapy is needed.

Not known (frequency cannot be estimated from available data):

• irritability;
• fluid retention and loss of appetite;
• abnormal perception of sounds such as ringing, buzzing, or hissing (tinnitus);
• severe heart disease (heart failure) and swelling (edema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, laryngeal obstruction, labored breathing (bronchospasm), temporary cessation of breathing (apnea), and difficulty breathing (dyspnea);
• worsening of inflammatory bowel diseases (colitis and Crohn's disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the esophagus (esophagitis);
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell);
• a widespread, red, scaly rash with formation of pustules under the skin and blisters mainly localized in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Decaflu Fever and Pain if you develop these symptoms and contact your doctor immediately. See also section 2. The use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Decaflu Fever and Pain

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening the bottle, store for a maximum of 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Decaflu Fever and Pain 100 mg/5 ml oral suspension contains
Decaflu Fever and Pain orange flavour
Each ml of oral suspension contains:

• active substance: ibuprofen 20 mg
• Other components: monohydrate citric acid, sodium citrate, sodium benzoate (see section “Decaflu Fever and Pain contains”), acesulfame potassium, xanthan gum, orange flavour, maltitol syrup (see section “Decaflu Fever and Pain contains”), glycerine, purified water.

Decaflu Fever and Pain strawberry flavour
Each ml of oral suspension contains:

• active substance: ibuprofen 20 mg
• Other components: monohydrate citric acid, sodium citrate, sodium benzoate (see section “Decaflu Fever and Pain contains”), acesulfame potassium, xanthan gum, strawberry flavour, maltitol syrup (see section “Decaflu Fever and Pain contains”), glycerine, purified water.

Description of the appearance of Decaflu Fever and Pain 100 mg/5 ml oral suspension and contents of the
pack
Decaflu Fever and Pain is an oral suspension, white or almost white in colour.
It is available in 150 ml bottles with a dosing syringe.
Marketing Authorisation Holder
Laboratorio Chimico Deca Dr. Capuani S.r.l.
Via Giotto 1
30172 Venice (VE)
Manufacturer
Decaflu Fever and Pain orange flavour

• Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)

Decaflu Fever and Pain strawberry flavour

• Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)
• Marco Viti Farmaceutici S.p.A. - Via Tarantelli, 13/15 - 22076 Mozzate (CO)